The FREEDOM-1 study was a randomized, placebo-controlled 39-week trial of 460 patients with type 2 diabetes whose HbA1c was not controlled by up to three other diabetes medications or diet and exercise alone. Participants received ITCA 650 40mcg/day, ITCA 650 60mcg/day, or placebo; the primary endpoint was HbA1c reduction over 39 weeks and secondary endpoints included weight loss and percentage of patients reaching goal HbA1c levels of <7%. Patients with both doses of ITCA 650 had statistically significant endpoints compared to those in the placebo arm.

In the open-label FREEDOM-1 HBL trial, 60 patients with type 2 diabetes and poor glycemic control were treated with ITCA 650 20mcg/day for three months and then ITCA 650 60mcg/day for the next six months. Significant reductions in HbA1c levels were observed by Week 6 and the change from baseline was sustained over time. Although weight reduction was not statistically significant, patients had a mean reduction in HbA1c of 3.4% at Week 39 and 22% of patients achieved HbA1c reductions of ≥4% or greater. Twenty-five percent of patients achieved an HbA1c level <7% at the LOCF endpoint.

If approved, ITCA 650 would be the first and only injection-free GLP-1 therapy to deliver up to a full year of treatment from a single device placement.